Register Your Anesthesiology Device in Mexico
Anesthesia machines, monitors, ventilatorsโwe handle COFEPRIS registration for the full range of anesthesiology equipment.
Free consultation โข No commitment required
30-365
Days to Market
500+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
Anesthesiology Devices Face Strict Scrutiny
Specialized devices need specialized expertise
Life-Critical Classification
Most anesthesiology devices fall into Class III. COFEPRIS scrutinizes safety systems, alarms, and fail-safes.
Complex Technical Dossiers
Gas delivery systems, monitoring accuracy, and biocompatibility data must meet COFEPRIS's demanding standards.
Extended Review Timelines
Without expert guidance, anesthesiology devices can stall in COFEPRIS review for 12+ months.
We Specialize in Anesthesiology Devices
Pure Global experts know your device category inside out
Deep Category Expertise
Specialist preparation of anesthesiology technical dossiers
Technical Documentation Excellence
Safety systems documentation that satisfies COFEPRIS reviewers
Proven Registration Track Record
Performance testing data presentation for gas delivery and monitoring
Ongoing Compliance Support
Post-market vigilance planning for critical care equipment
How It Works
Free Consultation
Share your device details. We'll confirm classification, assess your documentation, and provide an exact quote.
Expert Dossier Preparation
Our regulatory specialists prepare your complete submission with deep specialty knowledge.
Submission & Management
We submit on your behalf and manage the entire review process, including deficiency responses.
Market Your Device
Receive your registration. Your device is legally marketable for 10 years.
Trusted by Leading Anesthesiology Device Companies
โPure Global registered our anesthesia workstation in Mexico when we thought it would take years. Their team understood exactly what COFEPRIS needed.โ
Dr. Lisa Park
VP Regulatory Affairs, AirMed Systems
Transparent Pricing
Complete service, no hidden fees
Starting from
Starting from $2,000/year
Based on device class and complexitySave 60-80%
Ready to Register Your Anesthesiology Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.